Sekisui Spectrolyse PAI-1 recall
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human…
Why was Sekisui Spectrolyse PAI-1 recalled?
SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 120425 and 120601
- Product
- Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human…
- Recalling firm
- Sekisui Diagnostics Llc
- Quantity
- 699 kits
- Distribution
- Nationwide distribution: USA including states of: FL, IN, IL, and WA.
- Recall date
- September 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)